Production Operator Assembler I

Cretex•Bloomington, MN

1d•Onsite

About The Position

The Production Operator Assembler I is an entry-level position responsible for basic machine operation, inspection, assembly, packaging, and support tasks across multiple production areas. The employee follows established procedures, work instructions, and quality standards to produce medical device components and products. The position is based at QTS’s facility in west Bloomington, Minnesota (55438). Work may include assembly, production operations, or secondary operations, depending on the area and operating company. Tasks may include inspecting, assembling, and packaging medical devices; operating production or secondary equipment; monitoring quality and machine performance; and performing basic operator-level checks. Employees are expected to follow applicable quality, ISO, cGMP, and medical device regulatory requirements, maintain a clean and organized work area, complete production and quality documentation, and communicate issues promptly. QTS provides end-of-line services for medical device OEMs, including finished device assembly, packaging, and sterilization management. QTS was founded in 2001 and is part of the Cretex Medical family of companies. Its stated purpose is to have a positive impact on people, and its mission is to make it easier to get products to patients.

Requirements

Ability to work in a manufacturing environment.
Ability to read, write, and follow written instructions in English.
Ability to perform basic math and demonstrate hand-eye coordination and dexterity.
Ability to use basic hand tools and measurement equipment.
Clear and effective verbal and written communication skills.
Strong attention to detail and organizational skills.
Ability to work in a fast-paced team environment and handle multiple tasks.
Proficiency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.

Nice To Haves

High school diploma or equivalent.
At least 6 months of manufacturing, assembly, machine operation, or cleanroom experience.
Familiarity with FDA, ISO, cGMP, Lean manufacturing, or workplace safety practices.
Experience working with microscopes or inspection tools.

Responsibilities

Perform visual and/or dimensional inspections using microscopes, gauges, calipers, or other measurement tools as required.
Complete production records, quality checks, setup sheets, history records, and other required documentation.
Participate in continuous improvement initiatives and implement process enhancements.
Handle cleaning chemicals such as isopropyl alcohol, detergents, or solvents when needed.
Maintain an organized, clean work area in accordance with 5S expectations.
Participate in required training and company meetings.
Read, understand, and follow work instructions, standard work, and applicable quality, ISO, and cGMP requirements.
Cross-train across manufacturing areas.
Support and comply with the Quality System, ISO, and medical device regulatory requirements.
Promptly communicate issues with materials, equipment, or processes.
Inspect, assemble, and/or package components and medical devices according to customer specifications.
Operate hand tools and basic manual equipment used in assembly.
Use tray, band, or impulse sealing equipment.
Perform labeling, packaging, and final product presentation.
Operate production equipment or machines according to work instructions, ensuring correct materials, tooling, programs, and processes are used.
Monitor production processes, part quality, and machine performance, and escalate concerns as needed.
Perform basic preventive or operator-level machine checks, including cleanliness and safe-operation checks.
Perform secondary operations such as trimming, deburring, cleaning, laser marking, laser welding, and/or component finishing.
Operate designated secondary equipment or simple mechanical devices.
Inspect and verify part conformance after secondary operations.
Use basic measurement tools to verify accuracy, such as gauge pins, calipers, drop indicators, pull testers, and tape measures.
Perform other duties as assigned.

Benefits

401(k) retirement savings plan with company match contribution.
Onsite health clinics.
Discretionary holiday bonus program based on years of service.
Cretex University.
24/7 employee assistance program, including access to five confidential visits with a licensed counselor at no cost.
Wellness program with incentives.
Employee death benefit.
Employee sick and safe leave.
For employees working 20 or more hours per week: comprehensive medical insurance with access to virtual providers, dental insurance, vision insurance, a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts, paid holidays, paid time off, and discretionary profit sharing.
For employees working 30 or more hours per week: parental leave, accident and critical illness benefits, optional employee, spouse, and child life insurance, short- and long-term disability, company-provided life insurance, and tuition assistance programs.